Escher: science-driven drug regulationThe pharmaceutical arena is one of the most regulated sectors in our society. However, there is increasing concern that, apart from all the benefits of drug regulation, the balance sheet may have shifted towards over-regulation with apparent threats to drug innovation in general.

A major goal of regulating marketing authorization of medicines is to secure safe and effective drugs, but such regulations are also driving high costs of drug development; regulations affecting reimbursement and access to the market are key to cost-containment but may also provide major barriers for investors and industry to stimulate innovation.

Key objectives of this project are to identify, evaluate and remove regulatory bottlenecks hampering the efficiency in pharmaceutical innovation and stimulate factors helping innovation . The project encompasses three synergistic areas of research directed at regulatory barriers and opportunities in drug innovation, innovative models of testing, and monitoring efficacy and safety of new drugs and knowledge management, learning and education. A major achievement has been the agenda-setting function of the project towards stakeholders and politicians.

Background

Various analyses (Rawlins Nat Drug Discovery 2004, FDA Critical Path, EMEA Roadmap, EU Innovative Medicines Initiative, WHO Priority Medicines) have provided evidence that the current system of pharmaceutical innovation is not sustainable anymore, both from a economic point of view and from the perspective of unmet medical needs, therapeutic gaps and access to medicines. At the same time, lack of efficacy (25%) and clinical safety (12%) are still major reasons for drug development projects to be stopped prematurely. Insufficient predictive capability, complexities in essay sensitivity, lack of validated and accepted biomarkers are important hampering factors across virtually all the discovery, pre-clinical and clinical phases of drug development.